MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SILTEX ROUND MODERATE PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3542620
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2008
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: right deflation.Concomitant products: left side; 175cc mentor siltex round moderate profile; catalog number: 3542620; lot number: 247528; serial number: (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient of unknown age and race underwent primary breast augmentation with a 175cc mentor siltex round moderate profile and was presented with right side breast implant deflation postoperatively.As a result, the patient underwent explantation and replacement with catalog number 3501620; serial number (b)(4) on (b)(6) 2008.
Additional Manufacturer Narrative
A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX ROUND MODERATE PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9414265
• Report Number: 1645337-2019-25124
• Device Sequence Number: 17194133
• Product Code: FWM
• UDI-Device Identifier: 00081317001737
• UDI-Public: 00081317001737
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2006
• Device Catalogue Number: 3542620
• Device Lot Number: 247528
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention